Preprocedural Fasting and Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment of Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00263289
First received: December 7, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

Nitrous oxide analgesia is used routinely for the dental treatment of anxious or uncooperative pediatric patients. In many instances it is used alone without any supplemental oral premedication. A controversy exists among pediatric dentists and pediatric dental departments regarding the need to apply pre-procedural fasting (PF) or other limitations on children undergoing dental treatment with nitrous oxide alone.The purpose of this study is to investigate the association between PF and the frequency of vomiting in pediatric patients receiving dental treatment with nitrous oxide analgesia.


Condition Intervention
Vomiting
Procedure: preprocedural fasting

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Effect of Preprocedural Fasting on Vomiting Frequency in Children Administered Nitrous Oxide -Oxygen Inhalation Analgesia for Dental Treatment

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Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 100
Study Start Date: January 2006
Detailed Description:

Materials and methods The experimental protocol will be submitted for approved by the Institutional Human Subjects Ethics committee of Hadassah-Hebrew University School of Dental l Medicine. Informed consent will be obtained from all parents or legal guardians of participating subjects.

Subjects All pediatric patients attending the graduate student pediatric dental clinic of the Department of Pediatric Dentistry at Hadassah Clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. All participants must be in good health (ASA I). Prior to one session subjects will be restricted and have a preprocedural fasting as per the following guidelines: All subjects will be without solids (including milk) for at least 4 hours prior to nitrous oxide administration and without clear liquids 2 hours before treatment. On the alternative session subjects will have no restrictions on their food or liquid intake.

Evaluation

A survey will be given to parents prior to treatment and information regarding the following will be gathered:

Age, previous nitrous oxide experience, history of vomiting or nausea (motion sickness, foods etc), last mea: what and when? The resident administering treatment will record the following: Duration of inhalation administration, percentage of nitrous oxide and flow rate, steady or fluctuating, occurrence of vomiting during or immediately following treatment.

Statistical analysis of data will determine the incidence of vomiting and if any significant differences between the two sessions exist.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

- All pediatric patients attending the graduate student pediatric dental clinic of the Department of Pediatric Dentistry at Hadassah Clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. All participants must be in good health (ASA I).

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00263289

Locations
Israel
Hadassah Medical Organization,
Jerusalem,, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ari Kupietzky, DMD MSc Clinical Instructor, Department of Pediatric Dentistry, Hadassah School of Dental Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00263289     History of Changes
Other Study ID Numbers: n20kup-HMO-CTIL
Study First Received: December 7, 2005
Last Updated: December 7, 2005
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014